Analyte concentration determination in physiological samples is of ever increasing importance to today's society. Such assays find use in a variety of application settings, including clinical laboratory testing, home testing, etc., where the results of such testing play a prominent role in the diagnosis and management of a variety of disease conditions. Analytes of interest include glucose for diabetes management, cholesterol for monitoring cardiovascular conditions, and the like. In response to this growing importance of analyte concentration determination, a variety of analyte concentration determination protocols and devices for both clinical and home testing have been developed. Many such protocols employ test strips to perform the testing.
Before testing can begin, an individual seeking to determine the presence and/or concentration of an analyte in a physiological sample must first obtain a test strip, apply a sample thereto, and obtain the results, where the results are oftentimes obtained automatically with a meter and thus require the additional step of engaging an obtained test strip with a meter. However, this multi-step process is not without difficulty, especially for individuals who suffer from diminished hand-eye coordination and/or diminished finger sensation. For example, persons with diabetes typically have either or both impaired vision and diminished finger sensation or other dexterity problems. Such persons must use test strips to test their blood glucose levels a number of times a day.
To begin, a test strip must first be obtained. The ability to easily obtain a test strip, particularly a single test strip from amongst a plurality of test strips housed in a test strip container, may be difficult, for instance for those persons with diminished hand-eye coordination or finger sensation, as mentioned above. The typical test strip is only several millimeters in width and length and, thus, difficult to grasp and manipulate.
The most basic test strip containers are simple storage reservoirs where the test strips are retained inside and manually removed. However, it is often difficult to easily extract a test strip from these containers. These containers are usually shaped and sized to hold a plurality of test strips and to completely encompass the test strips inside so as to protect the test strips from light, humidity, and other environmental contaminants including oils and the like from an individual's hands, where such protection is necessary to insure the precision, accuracy and overall integrity of the test result.
An exemplary embodiment of such a simple test strip container is shown in FIG. 1. To obtain a single test strip from such a conventional test strip container to begin a test, an individual has two options for removing a test strip. In one option, an individual may simply turn the container upside down to pour a test strip out. This, as is apparent, has significant disadvantages as one or all of the test strips stored inside the container may quickly spill out and become contaminated or damaged. In a second option, an individual places a finger inside the container to try to grasp a single test strip from amongst a plurality of test strips without damaging or contaminating any of the strips in the process. However, such a method is difficult for individuals who have either or both impaired vision and diminished finger sensation and oftentimes results in an individual inadvertently contacting portions of the test strip that should not be touched, such as testing or reaction areas (i.e., areas on the strip having testing reagents, etc.) and the like, where such contact can impart contaminants and cause erroneous testing results. Similarly, other test strips may be inadvertently contacted resulting in erroneous testing results of those test strips as well.
More complex test strip containers have been developed to try to overcome some of the disadvantages associated with the simple test strip containers described above (see for example U.S. Pat. Nos. 5,575,403, 5,489,414; 5,630,986; 5,510,266). However, these, too, have certain disadvantages. For example, these devices often require a degree of physical dexterity and visual acuity that may be lacking in certain individuals who use the containers. Also, due to the complexity of the devices, i.e., the numbers of components forming the containers, the cost of manufacture increases and thus the cost to the user increases. Furthermore, typically such test strip containers require the test strips to be stacked in an orderly or precise manner therein. This too adds steps to the manufacturing process and thus increases costs.
In those instances where analyte concentration determination is performed automatically with a meter, once a test strip is finally obtained from a test strip container, the test strip must be associated with the meter, either before or after sample is applied thereto. Accordingly, grasping the test strip, an individual must engage the test strip with the meter so that the meter may “read” the test strip and determine the concentration of an analyte in the sample applied to the test strip. As is apparent, this increases complexity to the analyte concentration process and may be difficult for many individuals such as the above-described diabetic who might have diminished visual and/or finger sensation. Furthermore, while trying to manipulate the test strip into the appropriate position within the meter, an individual may inadvertently contact portions of the test strip that should not be touched thereby imparting contaminants thereto.
As such, there is continued interest in the development of new devices and methods for use in analyte concentration determination. Of particular interest would be the development of such devices and methods in which the test strip dispenser and meter are integrated into a single device, are easy and inexpensive to manufacture, have minimal components, are easy to use, particularly for visually and dextrally impaired individuals, are portable and which minimize damage and/or contamination to test strips.